4
Indication details
- Combined Agent(s)
- Pemetrexed + platinum‑containing ChT
- Control Arm
- Pemetrexed + platinum‑containing ChT
- FDA Therapeutic Indication
- Tisleizumab in combination with pemetrexed and platinum‑containing ChT is indicated for the first-line treatment of adult patients with NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations
- Trial Name
- RATIONALE 304
- NCT Number
- NCT03663205
- Trial Phase
- Phase III
Approval details
- FDA Approval
- No FDA approval
- EMA Approval
- EMA (CHMP) May 2024. EC decision July 2024
Primary Outcome(s)
- Primary Outcome(s)
- PD-L1 ≥ 50%: PFS (IRC) key secondary, OS exploratory (crossover allowed)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 4.6 months
- PFS Gain
- 6.9 months
- PFS HR
- 0.31 (0.17-0.57)
- OS HR
- Not reached
- ORR
- 20.5%
Adjustments
- Annotation
- Scoring refers to the PD-L1 ≥ 50% approved subgroup, with updated HRs for PFS: 0.29 (95% CI 0.16-0.50) and OS: 0.39 (95% CI 0.21-0.70) from Wang, 2024. Median PFS/OS are not provided for this subgroup
- QoL Comment
-
QoL improved
- Toxicity Comment
-
Hematologic AEs, Grade ≥3
Score (after adjustments)
- Preliminary non-curative score
-
3
- QoL adjustment
- +1
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 427
- Scorecard version
- 1
- Issue date
- 22.03.2024
- Last update
- 07.11.2024
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.